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  1. Home
  2. ISO 11135:2014

ISO 11135:2014 ✓ Most Recent

1880684  Preview

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

standard by International Organization for Standardization , 07/15/2014

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Identical Versions Available

  • BS EN ISO 11135:2014

    January 2015
    Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

    • Historical Version
  • DIN EN ISO 11135

    October 2014
    Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

    • Historical Version
  • AAMI/ISO 11135:2014

    July 2015
    Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

    • This is the most recent version of this document.
  • CAN/CSA Z11135:15 (R2020)

    November 2015
    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11135:2014, second edition, 2014-07-15)

    • This is the most recent version of this document.

Full Description

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

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Document History

  1. ISO 11135:2014

    You are currently viewing this product 👀 currently
    viewing

    July 2014
    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

    • Most Recent  Most Recent
  2. ISO/TS 11135-2:2008

    August 2008
    Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1

    • Historical Version
  3. ISO 11135-1:2007

    May 2007
    Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

    • Historical Version
  4. ISO 11135:1994

    February 1994
    Medical devices -- Validation and routine control of ethylene oxide sterilization

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 11135:2014/Amd.1:2018

    October 2018
    Amendment 1: Revision of Annex E, Single batch release

Browse related products from International Organization for Standardization

  • International Organization for Standardization > By ICS Code > 11: Health care technology > 11.080: Sterilization and disinfection > 11.080.01: Sterilization and disinfection in general
  • International Organization for Standardization > By Technical Committee > TC 198: Sterilization of health care products

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Price: $259.00
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Product Details

Published:

07/15/2014

Number of Pages:

88

File Size:

1 file , 1.1 MB

Same As:

BS EN ISO 11135:2014, DIN EN ISO 11135, AAMI/ISO 11135:2014, CAN/CSA Z11135:15 (R2020)

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